Study on a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Compared to a Meningococcal Reference Vaccine, and When Given Alone or With Two Other Vaccines in Healthy Adolescents
NCT ID: NCT04490018
Last Updated: 2025-09-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
463 participants
INTERVENTIONAL
2021-03-16
2022-05-11
Brief Summary
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To demonstrate the non-inferiority of the seroprotection rate (serum bactericidal assay using human complement \[hSBA\] titer greater than or equal to \[\>=\] 1:8) to meningococcal serogroups A, C, W, and Y following the administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate vaccine (MenACYW Conjugate vaccine) (Group 1) compared to a single dose of Nimenrix® (Group 2).
Secondary Objective:
To describe:
* the antibody response of meningococcal serogroups A, C, W, and Y measured by hSBA, before and 1 month following meningococcal vaccination administered alone (Groups 1 and 2) or concomitantly with 9-valent human papilloma virus (9vHPV) and tetanus, diphtheria, and acellular pertussis - inactivated polio vaccine \[adsorbed, reduced antigen(s) content\] (Tdap-IPV) vaccines (Group 3).
* the antibody response of meningococcal serogroup C measured by hSBA and serum bactericidal assay using baby rabbit complement (rSBA), before vaccination and at Day 31 after vaccination with MenACYW Conjugate vaccine or Nimenrix® (Groups 1 and 2) according to MenC primed status.
* the antibody response against antigens of 9vHPV and Tdap-IPV vaccines, before and 1 month following vaccination.
* the safety profile in each group after each and any vaccination.
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Detailed Description
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\* This was the first dose of 9vHPV, of the 2-dose or 3-dose series according to the local recommendations and age of the participant. These additional vaccinations for the completion of 9vHPV schedule took place outside of the objectives and scope of this study and thus were not described in this protocol.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
In Groups 1 and 2
* Investigators and study staff who conducted the safety assessment, participants, parents/legally acceptable representatives, the Sponsor, and laboratory personnel performing the serology testing were kept blinded to the vaccine received.
* Only the study staff who prepared and administered the vaccine and were not involved with the safety evaluation know which vaccine was administered.
In Group 3
\- Everyone involved in the study (i.e., Investigator, study staff, the Sponsor, participants, parents/legally acceptable representatives) know which vaccine was administered. This open-label design for Group 3 was due to the different vaccination schedule for this group than for Groups 1 and 2.
Study Groups
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Group 1: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
Participants received 0.5-milliliter (mL) intramuscular injection of MenACYW Conjugate vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after MenACYW vaccine) at Day 31.
Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine)
Pharmaceutical form: Liquid solution for injection Route of administration: Intramuscular
Human Papillomavirus 9-valent Vaccine (9vHPV)
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine (Tdap-IPV)
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Group 2: Nimenrix® + 9vHPV + Tdap-IPV Vaccines (Sequential Administration)
Participants received 0.5-mL intramuscular injection of Nimenrix® vaccine on Day 01 and 0.5-mL intramuscular injection of 9vHPV + Tdap-IPV vaccines (sequentially after Nimenrix® vaccine) at Day 31.
Meningococcal group A, C, W-135, and Y conjugate vaccine
Pharmaceutical form: Powder and solvent for solution for injection Route of administration: Intramuscular
Human Papillomavirus 9-valent Vaccine (9vHPV)
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine (Tdap-IPV)
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Group 3: MenACYW Conjugate Vaccine + 9vHPV + Tdap-IPV Vaccines (Concomitant Administration)
Participants received 0.5-mL intramuscular injection of MenACYW Conjugate vaccine concomitantly with 9vHPV + Tdap-IPV vaccines on Day 01.
Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine)
Pharmaceutical form: Liquid solution for injection Route of administration: Intramuscular
Human Papillomavirus 9-valent Vaccine (9vHPV)
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine (Tdap-IPV)
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Interventions
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Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine)
Pharmaceutical form: Liquid solution for injection Route of administration: Intramuscular
Meningococcal group A, C, W-135, and Y conjugate vaccine
Pharmaceutical form: Powder and solvent for solution for injection Route of administration: Intramuscular
Human Papillomavirus 9-valent Vaccine (9vHPV)
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine (Tdap-IPV)
Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Meningococcal serogroup C Conjugate vaccine (MenC) naïve participants or participants having received monovalent MenC priming in infancy (less than \[\<\] 2 years of age).
* Assent form had been signed and dated by the participant as per local regulation, and Informed Consent Form had been signed and dated by the parent/legally acceptable representative and by the participant if she/he turns 18 years old during the study.
* Participants and parent/legally acceptable representative were able to attend all scheduled visits and compiled with all study procedures.
* Covered by health insurance, if required by local regulations.
Exclusion Criteria
* Previous vaccination against meningococcal disease with either the study vaccine or another vaccine (i.e., polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, W, or Y; or meningococcal B serogroup-containing vaccine), except licensed monovalent MenC vaccination received before 2 years of age.
* Participation at the time of study enrollment (or in the 4 weeks preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
* Receipt of any vaccine in the 4 weeks preceding any study vaccination or planned receipt of any vaccine in the 4 weeks following any study vaccination except for influenza vaccination, which might receive at least 2 weeks before study vaccines. This exception included monovalent pandemic influenza vaccines and multivalent influenza vaccines.
* History of vaccination with any tetanus, diphtheria, pertussis, or inactivated polio virus vaccine within the previous 3 years.
* Previous human papilloma virus (HPV) vaccination.
* Receipt of immune globulins, blood or blood-derived products in the past 3 months.
* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
* History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.
* Known history of diphtheria, tetanus, pertussis, poliomyelitis, and/or HPV infection or disease.
* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a vaccine containing any of the same substances.
* Personal history of Guillain-Barré syndrome.
* Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within at least 10 years of the proposed study vaccination.
* Personal history of new or past encephalopathy, progressive or unstable neurological disorder, or unstable epilepsy.
* Verbal report of thrombocytopenia, contraindicating intramuscular vaccination.
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination.
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
* Current alcohol abuse or drug addiction.
* Chronic illness that, in the opinion of the Investigator, is at a stage where it might interfere with study conduct or completion.
* Moderate or severe acute illness/infection (according to Investigator's judgment) on the day of vaccination or febrile illness (temperature \>= 38.0 degree Celsius \[\>= 100.4 degree Fahrenheit\]). A prospective participant should not be included in the study until the condition had resolved or the febrile event has subsided.
* Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.
* Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e., parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
* Participant at high risk for meningococcal infection during the study (specifically but not limited to participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
10 Years
17 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Investigational Site Number :3480003
Budapest, , Hungary
Investigational Site Number :3480001
Győr, , Hungary
Investigational Site Number :3480002
Miskolc, , Hungary
Investigational Site Number :3480004
Szigetvár, , Hungary
Investigational Site Number :3480006
Szombathely, , Hungary
Investigational Site Number :3800005
Foggia, Apulia, Italy
Investigational Site Number :3800006
Catanzaro, Calabria, Italy
Investigational Site Number :3800002
Milan, Lombardy, Italy
Investigational Site Number :3800004
Palermo, Sicily, Italy
Investigational Site Number :3800001
Genova, , Italy
Investigational Site Number :7020002
Singapore, , Singapore
Investigational Site Number :7240001
Seville, Andalusia, Spain
Investigational Site Number :7240002
Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number :7240005
Esplugues de Llobregat, Castille and León, Spain
Investigational Site Number :7240006
Santiago de Compostela, Galicia [Galicia], Spain
Investigational Site Number :7240003
Madrid, Madrid, Comunidad de, Spain
Investigational Site Number :7240011
Burriana, Valenciana, Comunidad, Spain
Investigational Site Number :7240007
Puçol, Valenciana, Comunidad, Spain
Investigational Site Number :7240008
Valencia, Valenciana, Comunidad, Spain
Investigational Site Number :7240004
Valencia, Valenciana, Comunidad, Spain
Investigational Site Number :7240009
Valencia, Valenciana, Comunidad, Spain
Investigational Site Number :7240010
Valencia, Valenciana, Comunidad, Spain
Investigational Site Number :7240012
Valencia, Valenciana, Comunidad, Spain
Countries
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References
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Diez-Domingo J, Simko R, Icardi G, Chong CP, Zocchetti C, Syrkina O, Bchir S, Bertrand-Gerentes I. Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine Versus Nimenrix in Healthy Adolescents: A Randomized Phase IIIb Multicenter Study. Infect Dis Ther. 2024 Aug;13(8):1835-1859. doi: 10.1007/s40121-024-01009-x. Epub 2024 Jul 2.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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MEQ00071 Plain Language Results Summary
Other Identifiers
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2020-001665-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1249-2973
Identifier Type: REGISTRY
Identifier Source: secondary_id
MEQ00071
Identifier Type: -
Identifier Source: org_study_id
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